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FDA 510(k)

ITI STENT

K-Number: K980290 · 1998-07-21

Decision Date1998-07-21
Product CodeFGE
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ITI STENT is the device name listed in this FDA 510(k) record. The listed applicant is Intratherapeutics, Inc.. It received FDA 510(k) clearance on 1998-07-21 under 510(k) number K980290. The device is classified under product code FGE. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ITI STENT?

ITI STENT is a medical device that received FDA 510(k) clearance on 1998-07-21. The listed applicant is Intratherapeutics, Inc.. The 510(k) number is K980290.

When did ITI STENT receive FDA 510(k) clearance?

ITI STENT received FDA 510(k) clearance on 1998-07-21, under 510(k) number K980290.

Who is the listed applicant for ITI STENT?

The FDA 510(k) record lists Intratherapeutics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ITI STENT?

The FDA product code for ITI STENT is FGE.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Other records listing Intratherapeutics, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

View all 15 devices →

Related Devices (Code: FGE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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